Parenteral solution container with supporting means



Sept. 28, 1965 R. w. BARTON ETAL 3,208,710

PARENTERAL SOLUTION CONTAINER WITH SUPPORTING MEANS Original Filed Oct.14. 1960 2 Sheets-Sheet l 2 Sheets-Sheet 2 egg R. W. BARTON ETALPARENTERAL SOLUTION CONTAINER WITH SUPPORTING MEANS Original Filed Oct.14, 1960.

Sept. 28, 1965 Unted States Patent O 3,208,710 PARENTERAL SOLUTION4CONTAINER WITH SUPPORTHNG MEANS Raymond W. Barton, Evansville, Ind.,Hermann Heckel,

Oxford, Ohio, and Paul Prickett and Edward G. Swenson, Evansville, Ind.,assignors, by mesne assignments, to Don Baxter, Inc., Glendale, Calif.,a corporation of Nevada Original application Oct. 14, 1960, Ser. No.62,585, now Patent No. 3,161,310. Divided and this application Apr. 20,1964, Ser. No. 365,550

3 Claims. (Cl. 248-359) This application is a division of the inventorscopending application Serial No. 62,585, filed October 14, 1960, nowPatent No. 3,161,310.

This invention is concerned with a parenteral solution container havingmeans to support this container in either an upright or an invertedposition.

Parenteral solutions, designed for infusion or intravenous feeding ofpatients have commonly been packaged in glass bottles of varying sizes.Glass bottles are quite heavy, relatively expensive, subject to breakagewhen mishandled and provide a disposal problem for the hospital, as theyare not consumed by incineration.

Efforts have been made to provide plastic solution containers ofsynthetic plastic materials. Most of the work in this field has beenconcentrated on collapsible bags of plastic film materials, but thistype of container presents several serious problems. A plastic bag isnot self-supporting and if, as frequently happens, the administration ofa solution must be interrupted to switch to blood, the administrationapparatus is disconnected from the solution container and the remainingsolution runs out. The lack of sufficient rigidity to be self-supportingmakes filling extremely difficult; and in practice the containers areformed and filled simultaneously. Automatic machines for performingthese operations are relatively slow as compared with bottle-fillingmachines, adding to the manufacturing costs. In addition, suchcontainers must be heat sealed with liquid in them. It is difiicult tomake seals of this character with consistent quality in a productionoperation.

Another problem with plastic film containers is that water vapor escapesthrough the container walls. If the containers are stored for a periodof time even as short as six to nine months, the concentration of thecontents may be seriously increased.

A principal object of this invention is the provision of a moldedplastic bottle having adequate strength and sufficient clarity to permitvisual inspection of the contents and having aitemperaturecharacteristic allowing the use of heat sterilization, as in anautoclave.

One feature of the invention is the provision of a containerparticularly designed for parenteral solutions, including a bottle ofblow-molded, intermediate density polyethylene plastic material; andpreferably the bottle, which is partially deformable but not completelycollapsible, has a first portion provided with a rupturable diaphragmfor connection with an administration set and another portion providedwith a resealable diaphragm for insertion of an air inlet device.Another feature of the invention is that the solution bottle issubtsantially completely filled with parenteral solution and has aminimum air space therein. As will appear, the substantially completefill reduces the possibility of distortion of the container duringsterilization.

A further feature is that the container has a panel of transparent tapeadhesively secured to a wall thereof to improve the transmission oflight therethrough, permitting visual inspection of the contents.

3,208,710 Patented Sept. 28, 1965 Mlce Still another feature of theinvention is that the bottle has a recessed bottom portion with acentrally located depending tab, having an open space therearoundbetween the tab and the peripheral portion of the bottle bottom. Asuspension means for the bottle is attached to the tab and disposablewithin the open space surrounding the tab when the bottle rests on thesurface. A further feature is that the suspension means for the bottlecomprises a length of plastic tubing having its ends telescoped andsealed together.

Yet another feature of the invention is the provision of a bottle ofmolded plastic material having an indented area formed in the wallthereof with a pad of puncturable resealable material located in theindented area and a covering of a tape-like material overlying the padand adhered to the adjacent container wall; and more specifically, firstand second indented areas are formed adjacent each other with the end ofthe tape-like material extending partially over the second indented areato facilitate the removal of the tape.

And a further feature of the invention is the method of packaging asolution in a plastic container which comprises providing the containerwith a support, filling the container and sterilizing the supportedcontainer and contents at a temperature above the softening temperatureof the plastic material. Another feature of the packaging method is thatthe container is substantially completely filled, minimizing the airspace therein and reducing the possibility of distortion or deformationof the container during autoclaving.

A further feature of the invention is the method of applying a tapepanel to the wall of the container which includes the step of warmingthe container to an elevated temperature and applying the tape panel atthe elevated temperature, permitting1 the adhesive to fill theirregularities of the container surface. Still another feature is thestep of wetting the surface of the container with an adhesive solventbefore applying the tape, to cause the adhesive to conform intimatelywith the irregularities of the surface.

And a further feature of the invention is the provision of an air inletfilter device for a plastic parenteral solution container in which meansare provided for preventing the solution wetting the filter material.More specifically, the filter device includes an elongated body with acannula at one end for insertion into the container and a mass of filtermaterial at the other end, remote from the cannula. In an alternativestructure, the air inlet device includes a manually operable valvemember between the cannula and the filter material.

Further features and advantages of the invention will be apparent fromthe following specification and from the drawings in which:

FIGURE 1 is an elevational view of a container embodying the invention;

FIGURE 2 is an elevational view of the container in use, with aninfusion set connected thereto;

FIGURE 3 is an enlarged fragmentary sectional view of the lower portionof the container, illustrating the supporting arrangement;

FIGURE 4 is an enlarged fragmentary sectional view taken generally alongthe line 4-4 of FIGURE 6, illustrating the air intake resealable pad andits mounting;

FIGURE 5 is an enlarged fragmentary sectional view of the neck of thecontainer and the closure therefor;

FIGURE 6 is a fragmentary elevational view of the resealable entry pad;

FIGURES 7-9 are diagrammatic views illustrating steps of the filling andsterilizing method according to the invention;

FIGURE 10 is an elevational view, partially in section, of an air inletlilter device for use with the plastic container;

FIGURE 11 is a fragmentary view, partially in section, of a modified airfilter; and

FIGURE 12 is a sectional View of another modified air filter.

Several basic requirements for parenteral solution containers must bemet in adapting a plastic material for such use. One of the mostimportant requirements relates to the ability to withstand elevatedtemperatures, for an extended period of time. Most parenteral solutionsprovide an excellent medium for bacterial growth, and must be sterilizedin the final container unless the filling operation is carried on understerile conditions, which is generally so diicult that it iseconomically unfeasible. Furthermore, the most practical sterilizationprocedure for parenteral products is to heat the illed containers to atemperature in excess of 220 F., and maintain it at the elevatedtemperature for a period, as of the order of one-half hour. Such anoperation is normally carried on in an autoclave and is often referredto as autoclaving Accordingly, it is necessary that the plastic materialused be such that it will not fail at this elevated temperature. This initself is not too diicult to attain with the presently availableplastics, such as the high density polyethylenes. However, anotherimportant requirement is that the container be such that the contentscan be visually inspected before use, with suicient clarity to permitobservation of small particles, such as may be caused by formation of aprecipitate in the solution. Hence, the material must permit relativelyundiffused passage of light through the container walls.

In addition, the container must have suicient strength to withstandhydrostatic shocks incurred during handling and shipment and must not besubject to stress failures during aging, as the products may be storedfor some time before use.

A further requirement is that the plastic material shall not permitcontamination of the contents over a period of time, either directlyfrom the plastic itself, or by the slow diffusion or migration ofair-borne contaminants through the container wall.

As pointed out above, high density polyethylenes provide the heatresistance required for autoclaving. However, they do not have sucientclarity to permit visual inspection of the contents of the container.Certain polyvinyl plastics have the heat resistance and clarity whichare required, but have been found to introduce contamination after aperiod of storage; and are relatively expensive.

A medium density polyethylene material, as Alathon 34, a product of E.I. du Pont de Nemours & Co., has been found satisfactory when thefilling and processing are carried on in accordance with the invention.

Turning now to the drawings, a container embodying the invention isillustrated in FIGURE 1. Container 20 is bottle-like in conguration, andhas an opening defined by a neck 21 closed by a cap 22 which is in turncovered by a plastic film seal 23. The container or bottle 20 has agenerally square cross-section with rounded corners for maximum strengthwith greatest economy of space for packaging and storage. In a onelitersize container, utilizing the medium density polyethylene materialspecified above, the thickness of the side panels of the container,which are the thinnest portion of the bottle, is of the order of 0.015inch. This is the minimum thickness obtainable with present moldingtechniques to achieve a bottle with sufficient strength, particularly inthe bottom portion thereof, to withstand the stresses of handling. Alabel 24 fixed to the side wall of the container 20 carries suitableidentifying indicia for the parenteral solution, and also providesgraduated scales indicating the quantity of solution in the container.Two reversely related scales are desirable,

so that the quantity of solution may be determined whether the containeris upright or inverted.

FIGURE 2 illustrates the container 20 as it is used in dispensing thesolution. The container is hung in an inverted position by a supportingelement or suspension member 26 from a suitable carrier 27, as a hook.An administration set 28 has a part 29 with a cannula or spike 30 whichis inserted through an outlet in neck 21 of the container, forconducting the solution to a patient. Air is admitted to the container20 through a filter 32 suitably connected with the container, as willappear.

The suspension arrangement for the container is best seen in FIGURE 3.The bottom portion 34 of container 20 is formed inwardly defining arecess surrounded by a peripheral bottom portion 35. Centrally locatedin the recess is a diagonally extending depending tab 36, provided withan aperature 36a through which the suspension member 26 extends. Aplurality of feet 37 are formed on the bottom of the peripheral portionof 35 of the container and hold the peripheral portion spaced from asupporting surface 38 on which the container may stand in an uprightposition. The downward extent of depending tab 36 is such that its lowerextremity is spaced above the supporting surface. The suspension member26 is received within the recess surrounding tab 36 and may extendoutwardly between the peripheral bottom portion 35 of the container,between the feet 37, without interfering with the stability of thecontainer.

The suspension member 26 preferably comprises a length of vinyl plastictubing having its end portions telescoped and sealed together. Theplastic tubing supporting element is extremely flexible and readilyassumes such configuration or conformation as may be necessary to permitthe container to stand in steady condition on a supporting surface. Thesupporting element normally has a generally circular configuration, whenit is not acted on by an outside force, and, when the container isinverted, may readily be attached to a hanger. The support 26 ispreferably assembled by threading a length of the plastic tubingmaterial through the opening 36a in the tab, dipping one end in asolvent for the plastic and then telescoping the ends of the tubing.When the solvent evaporates, the ends are iirmly welded together.

The neck 21 of container 20 -is provided with :a plug or tment 40 whichserves as a closure for the container and also provides for theconnection thereto of a suitable administration apparatus. The plug ispreferably of polyethylene material, and `has an outwardly extending rim41 which seats on the surface of the neck 2.1 yof the container,properly positioning the plug in the neck. After insertion, the plug isheat sealed in place, 'bonding the interface between the inner surfaceof the neck and the outer Wall surface of the plug. lrl`h'e plug iscentrally recessed and is provided with an upstanding central tubularportion 42 closed at its inner end by an integral, rupturable diaphragm43. The inner diameter of tubular p0rtion 42 is such that it seals withthe surface lof the spike or cannula 30 of the administration set uponinsertion thereof to a depth less than that sufficient to cau-se thepointed end portion to rupture the diaphragm. 'Ihis prevents leakage ofthe contents during the attachment of the .administration set.

Inasmuch as the container 20 is only :slightly deformable orcollapsible, it is necessary to provide for the entry of air t-o permitthe contents to flow out through the administration set. A wall 'of thecontainer, adjacent the bottom thereof, is provided with a pair ofindented or depressed areas 46 and 47, with the area 47 being adjacentt'o and directly below the area 46. A disc of resealing rubberymaterial, as a gum rubber, is affixed to the indented `area 46 andprovides for the insertion of the spike of an air inlet and filterdevice. The resealing disc 48 preferably has laminated thereto a layerof doublesided, pressure-sensitive, tape 49 having a polyvinyl etheradhesive which has been found to adhere `satisfactorily to the plasticcontainer wall. By double-sided is meant a tape which has apressure-sensitive adhesive on both surfaces thereof. The tape 49 thenserves as the means for securing the disc 4S to the container wall. Thesterility of the disc 48 is maintained during handling and storage by acovering of tape 50 having a layer of adhesive on one side, whichoverlies the disc and is sealed to the wall of the container around thedisc and indented area 46. An end portion 50u of the tape strip extendspartially over the lower indented area 47 providing a readily manuallyengageable surface for grasping the tape to remove it The procedurefollowed in filling and sterilizing the container is particularlyimportant in permitting the practical utilization of polyethyleneplastic material as the container. The preferred sequence of steps inthe filling and the sterilizing operation are illustrated in FIG- URES7-9. In FIGURE 7, the plastic container 20 is shown received in asupporting sleeve or canister 54 which conforms generally with the shapeof the empty container and holds it during the lling and sterilizingoperation. The container 20 preferably has a sliding fit inside thesupporting canister 54. Supporting canister v54 is preferably of .areasonably rigid construction, as of sheet aluminum, and is providedwith feet 55 which support the bottom in spaced relation from asupporting surface 56 to permit circulation of steam Iabout thecanister. A slot extends across the bottom of the canister to allowsteam to enter and reach container 20. The slot is so located thatdiagonally extending tab 36 cannot enter it.

The empty container 20 is placed in the canister 54 and then filled, asfrom a suitable filling head 57. The parenteral solution is preferablydelivered to container 20 at an elevated temperature, as of the order of140- 190 F. This serves two functions: first, it .reduces the quantityof dissolved gases in the parenteral liquid which might be driven offand stretch the bottle during autoclaving; and second, it reduces thetime required to bring the filled containers to sterilizationtemperature in the autoclave. The container 20 is as nearly completelyfilled 'as possible, minimizing the quantity of air trapped therein.This reduces the danger of distortion of the container by high pressuregas when the plastic walls are softened during autoclaving. The filledcontainer is provided with closure plug 40 which is sealed in place.

A quantity of the filled and supported containers 20 are then placed inan autoclave 58, FIGURE 8, in which they are held on spaced shelves 59.Steam is introduced into the autoclave, as through valve 60, at atemperature of the order of 230 F. for the medium density polyethylenematerial described above. This condition is maintained for a period ofthe order of thirty minutes to insure complete sterilization of theproduct. The temperature `at which autoclaving is carried on requires apressure of the order of 8-10 pounds per square inch. The sterilizationtemperature is in the range in which the plastic material softens and isreadily deformable. The support provided by canister 54 and the absenceof an excessive volume of air in the container reduce this problem.

Following the au'toclaving period, the steam within the autoclave 58 isvented, and cooling water, as at a temperature of 190 F. introduced, asthrough valve `61. An over-riding air pressure of the order of 12-16pounds per square inch is introduced into the autoclave through valve 62before or cuncurnently with the venting of the steam. After the bottlesare suitably cooled, they are removed from the autoclave 58, the uppersurfaces of the plug sterilized ,and cap 22 applied.

The label 24 which carries identifying indicia and graduationsindicating the quantity of liquid in the container, serve furtherpurposes. Molding procedures make it desirable to have :a roughenedsurface on the container to facilitate removal from the mold. Thissurface irregularity diffuses light passing therethrough renderingimpo-ssible visual observation and inspection of the contents with theaccuracy of clarity necessary. However, it has been found that if alayer of clear plastic material is adhered to the container surface, theclarity of the container is markedly increased. It is believe-d that thepenetration of the adhesive on the tape into the irregularities of thesurface of the blow-molded container reduces the diffraction ordispersion of light passing therethrough, and permits the requiredvisual inspection. It is preferable that adhesive-coated panels beapplied to opposite walls of the container, for maximum lighttransmission :and clarity. The adhesive on the tape must be ofSufficient thickness and have adequate flow characteristics to penetrateinto the surface irregularities of the plastic material. The results areimproved by applying the tape panels when the containers are warm or atan elevated temperature, permitting the adhesive to flow into theirregularities of the surface more freely; or by wetting the surfacewith an adhesive solvent, as alcohol or an alcoholglycerine mixture,prior to the application of the panel. Transparent cellophane tapemarketed by Minnesota Mining and .Manufacturing Company under thetrademark Scotch has been found satisfactory.

The indicia-bearing tape panels have the further beneficial effect ofincreasing the effective strength of the container, reducing thepossibility of rupture during handling.

The air entry patch 48 and its covering tape strip 50 are preferablyapplied to the wall of the container prior to filling. The adhesive bondbetween the patch and the bottle wall is improved by the pressureapplied thereto as a result of the weight of the container contents,while the container is confined within the sleeve 54, and at the sametime heated to a point where the adhesive is intimately bonded with boththe patch and the container wall.

For proper utilization of the resilient plastic parenteral container 20,a `specially designed air inlet-filter device is desirable. When thespike of the air inlet is forced through the wall of the container, itrequires the application of a substantial pressure on the container. Theresulting deformation of the container places the contents underpressure and may force some of the contents into the air inlet devicewetting the filtering medium and rendering it relatively unfit for use.

A novel air inlet and filter device construction is illustrated inFIGURE 10. The filter body 65 is elongated, and has a sharpened cannulaor spike 66 at one end thereof, for insertion through the wall of thecontainer. The body 65 is elongated in a direction generally coaxiallywith the spike 66 and is provided at its outer end, remote from thespike, with a mass 67 of a suitable filtering material as sterilecotton. The spacing between the spike and filter material is preferablyof the order of one inch. The outer end of the elongated filter body hasa pair of air inlet holes 68 formed therein, and suitably closed priorto use as by a cap 69. If desired, a strip lof adhesivecoated tape 70may be affixed to the outer end of shoulder body 65, overlying the airinlet holes 68. The tape may be lifted up to permit air to flow into theholes and replaced at will, to control the entry of air into thecontainer, and thus the administration of the parenteral solution.

A modified construction is shown in FIGURE 1l where the air inletopening 72 is formed in the end wall of the filter body 73, immediatelyadjacent the filter material 74. A removable and replaceable rubber cap75 is fitted over the end of the filter body to close the opening 72.

Still a further modification of the air inlet and filter device isillustrated in FIGURE 12. Here the filter body 78 has a cannula 'orspike portion 79 extending from the end wall thereof and filter material80 is carried in the cup-like filter body. A valve member 81 is providedin the air inlet body and seats against the end wall from which thecannula projects. The valve is provided with a valve stem 82 having aportion 82a which extends into the bore 79a of the spike 79 serving as aguide for the movement of valve 81. The second portion 82h of the valvestern extends outwardly through the lilter material 80 to permitmanipulation of the valve. With the air filter and inlet of FIGURE 12,the spike is inserted through the wall of the container 20 with thevalve 81 in closed position. This prevents any of the contents of thecontainer from flowing outwardly and wetting the lter material. Thevalve 81 may then be opened by pulling outwardly 'on valve stem portion8211, admitting air when it is desired to administer the solution.

While we have shown and described certain embodiments of our invention,it is to be understood that it is capable of many modifications.Changes, therefore, in the construction and arrangement may be madewithout departing from the spirit and scope of the invention asdisclosed in the appended claims.

We claim:

1. A parenteral solution container of the character described,comprising: a bottle having a recessed bottom portion with a centrallylocated depending tab; a plurality of feet spaced about the peripheryabout said bottom portion for supporting said container on a surfacewith the tab and the peripheral portion of the bottom spaced from saidsurface; and suspending means for said container attached to said taband extendable outwardly through the space between said peripheralportion of bottom surface and said support surface.

2. A parenteral solution container of the character described,comprising: a bottle having a centrally located recessed bottom portionwith a depending tab located centrally therein, there being an openspace completely around said tab between the tab and the peripheralportion of the bottle bottom; and suspension means attached to said taband disposable within said open space sur'- rounding the tab when thebottle rests on a surface.

3. A parenteral solution container of the character described,comprising: a bottle having a centrally located recessed bottom portionwith a depending tab located centrally therein, there being an openspace completely around said tab between the tab and the peripheralportion of the bottle bottom, said tab having an opening therein; andsuspension means extending through the opening in said tab comprising alength of plastic tubing having its ends telescoped and Sealed together.

References Cited by the Examiner UNITED STATES PATENTS 2,065,012 12/36Mulford 248-318 2,099,484 11/ 37 Hokerk 248-359 2,635,604 4/ 53Fredrickson 128-272 2,739,829 3/56 Pedlow et al 285-21 2,750,769 6/56Yost et al 65-15 2,983,639 5/61 Jageman 156-82 2,999,387 9/ 61 Andelin73-427 CLAUDE A. LE ROY. Primary Examiner.

1. A PARENTERAL SOLUTION CONTAINER OF THE CHARACTER DESCRIBED,COMPRISING: A BOTTLE HAVING A RECESSED BOTTOM PORTION WITH A CENTRALLYLOCATED DEPENDING TAB: A PLURALITY OF FEET SPACED ABOUT THE PERIPHERYABOUT SAID BOTTOM PORTION FOR SUPPORTING SAID CONTAINER ON A SURFACEWITH THE TAB AND THE PERIPHERAL PORTION OF THE BOTTOM SPACED FROM SAIDSURFACE; AND SUSPENDING MEANS FOR SAID CONTAINER ATTACHED TO SAID TABAND EXTENDABLE OUTWARDLY THROUGH THE SPACE BETWEEN SAID PERIPHERALPORTION OF BOTTOM SURFACE AND SAID SUPPORT SURFACE.